Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures

Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures: a Prospective, Randomized Clinical Trial

The purpose of this study is to compare the clinical and radiographic results of patients with midshaft clavicular fractures treated with plates or intramedullary flexible nails fixation.

Study Overview

• Status: Completed
• Conditions: Clavicle Fracture
• Intervention / Treatment: Procedure: Plate fixation; Procedure: ESIN

Detailed Description

Midshaft clavicular fractures are classically treated with non-surgical methods, supported by many authors as an effective treatment. However, different researches have shown high rates of nonunion and clavicle malunion related to the nonoperative treatment. Currently, indications for surgical treatment are wider and include mainly the following: shortening greater than or equal to 2.0 cm, multiple trauma, open fractures or with imminent exposure and associated neurovascular injury.

Plate fixation of midshaft clavicular fractures is widely described in the literature, and is considered the gold standard by different authors, associated with a high union rate and a low complication rate. Different types of plates have been used, including reconstruction plates, dynamic compression plates (DCP), low-contact dynamic compression plates (LC-DCP), semi-tubular plates, and pre-molded locking plates. Possible complications are postoperative infection, hardware loosening or failure, peri-incision paresthesia, neurovascular iatrogenic lesions, nonunion, and hardware related symptoms.

Elastic stable intramedullary nailing (ESIN) technique has been used in recent years in the treatment of midshaft clavicular fractures. Different studies report excellent functional results and low complication rates. Some theoretical advantages in relation to plates are the 3-point flexible nail support, which provides superior biomechanics resistance and uses the relative stability principle, favoring callus formation. When compared to plain steel wires, titanium nails have lower migration risk, due to its greater flexibility and better bone fixation.

The purpose of this study is to compare the clinical and radiographic results of patients with midshaft clavicular fractures treated with reconstruction plates or ESIN.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403-010
    • University of Sao Paulo - Department of Orthopedics and Traumatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Displaced Fractures of the middle third of the clavicle (no contact between the main fragments)
2. Age between 16 and 65 year old;
3. Terms of consent signed by the patient or guardian.

Exclusion Criteria:

1. Fracture of medial or lateral third of the clavicle;
2. Cortical contact between the main fracture fragments;
3. Age below 16 years old or more than 65 years old;
4. Pathological fracture;
5. Ipsilateral previous injuries of the shoulder or upper limb;
6. Ipsilateral associated fractures of the shoulder or upper limb;
7. Neuro-vascular injury associated;
8. Open fracture not eligible for primary internal fixation;
9. Clinical contraindication for surgery;
10. Fracture older than 30 days;
11. Patient not cooperative or ineligible for the follow-up;
12. Lack of consent to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Plate fixation; Reconstruction plate	Procedure: Plate fixation; Reconstruction plate
Active Comparator: ESIN; ESIN (Elastic Stable Intramedullary Nailing)	Procedure: ESIN; ESIN (Elastic Stable Intramedullary Nailing)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DASH score	Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DASH score	Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)	12 months
Constant-Murley Score	Shoulder functional score (0: worst function; 100: best function)	6 and 12 months PO
Time to Union	Time necessary to reach complete union measured in weeks	Monthly
Radiographic residual shortening	Clavicles shortening compared to the contralateral side	6 months
Patient satisfaction with the treatment	Subjective measurement. Patients are questioned about their satisfaction with the treatment instituted. Binary outcome.	6 and 12 months
Complication rate	Complications were divided in Minor and Major, as follows: Minor: paresthesia, transient neurologic deficit, implant deformation, partial implant migration, acromioclavicular or sternoclavicular pain, hardware related pain Major: permanent neurologic deficit, total implant failure, total implant migration, refracture, reoperation, nonunion	Monthly

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Fernando B Andrade-Silva, MD, University of Sao Paulo - Department of Orthopedics and Traumatology

Publications and helpful links

General Publications

• Andrade-Silva FB, Kojima KE, Joeris A, Santos Silva J, Mattar R Jr. Single, superiorly placed reconstruction plate compared with flexible intramedullary nailing for midshaft clavicular fractures: a prospective, randomized controlled trial. J Bone Joint Surg Am. 2015 Apr 15;97(8):620-6. doi: 10.2106/JBJS.N.00497.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: May 23, 2011
• First Submitted That Met QC Criteria: August 3, 2011
• First Posted (Estimate): August 4, 2011

Study Record Updates

• Last Update Posted (Estimate): April 28, 2014
• Last Update Submitted That Met QC Criteria: April 25, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: fracture; flexible; clavicle; plate; ESIN; midshaft; clavicular; intramedullary; nailing
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: IOT-HCFMUSP